1. Overview.- 2. Approaches to the Development and Use of PROs: A Unified Framework.- 3. An Illustration of the New PRO Measure Development Roadmap Using an Example from Skin Disease.- 4. Determination of Fitness for Purpose: Content Verification by Patients and Experts.- 5. Conventional Methods Meeting Modern Techniques: Factor Analysis Versus Rasch Analysis.- 6. Assessing the Performance of PROs Against Expectation: Psychometric Calibration.- 7. Integrating Patient Reported Outcomes in Clinical Trials, Routine Clinical Practice and Medicines Development Programmes.
Dr Paul Kamudoni (PhD MSc.) is a Scientific Associate Director in
the Global Evidence and Value Development - R&D department at
Merck KgaA in Darmstadt (Germany) where he leads the Centre of
Excellence for Patient Reported Outcomes. Dr Kamudoni trained as a
Pharmacoeconomist and a Clinical Outcome Measurement Scientist at
Cardiff University. In his day to day work, he is involved in the
development and validation of PRO measures, and the design and
integration of PRO endpoints in clinical trials and other types of
studies. He maintains an active research interest in methodological
issues in the integration of electronic health records with
prospective PRO assessments, and the application of item response
theory in PRO measurement among others.Dr Nutjaree Pratheepawanit
Johns (PhD PharmD) is an Associate Professor at the Faculty of
Pharmaceutical Sciences, and melatonin research group, Khon Kaen
University, Thailand. She has held a number of academic positions
both in Thailand and abroad, including a fellowship at the Western
Institutional Review Board (WIRB) (Olympia, WA, USA). Dr Johns has
an expertise in cancer care and quality of life (QoL) research and
collaborates with several cancer centres in Northeastern Thailand.
She has developed and tested a number of PRO measures including
cross-cultural adaptation into the Thai language. Dr Johns is also
a principal investigator in many clinical trials investigating the
effects of disease or interventions on QoL of cancer patients. She
has been a recipient of several prestigious awards including
Scholarship for Developing Country, International Society for
Quality of Life Research and the Doyle Prize: Postgraduate section,
Palliative Medicine Journal.
Professor Sam Salek (PhD RPh FFPM FRPS MCMS FESCP) is Professor of
Pharmacoepidemiology at the University of Hertfordshire, Hatfield,
visiting Professor at the Estate of Hessen, Germany, and Director
of the Institute for Medicines Development, Cardiff, UK. Professor
Salek's research focuses mainly on four areas: development and
application of PRO measures; drug safety evaluation and
pharmacovigilance; pharmacoeconomics and economic evaluation of
healthcare; and pharmaceutical regulation & medicines development
in the mature and emerging markets. He has published 22 books and
600+ journal articles and abstracts. Professor Salek is a member of
five Editorial Boards and an active member of several
societies.
"This is a very detailed outline of a new process that moves away from the traditional models of outcomes research and quantifies the value in the eyes of the patient, which is frequently lost in traditional outcomes assessment. It is an extraordinarily valuable read for policy makers at all levels." (Vincent F Carr, Doody's Book Reviews, January, 25, 2019)
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